NDMA in Metformin: Update | RxWiki Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) has posted lab results that show NDMA in some metformin products.

Metformin is a common medication used to treat high blood sugar in those with type 2 diabetes. NDMA is a nitrosamine impurity that is also referred to as N-nitrosodimethylamine. This impurity is thought to cause cancer.

Over the last several months, several medications have been recalled due to this possible cancer-causing impurity. These recalls are due to possible nitrosamine impurities in medications used for high blood pressure and acid reflux.

These medications include but are not limited to the following:

  • Ranitidine products
  • Losartan
  • Valsartan
  • Irbesartan

Regarding the metformin products that have been tested, the FDA stated that the NDMA levels were either not detectable or at a low level.

None of the products that have been tested have exceeded the acceptable daily intake for NDMA, the FDA noted. At this time, there are no recalls for metformin products.

We are exposed to nitrosamines every day, the FDA noted. Nitrosamines are in water and food (meat, dairy and vegetables) at low levels.

The FDA said it will continue to evaluate the risk tied to exposure to nitrosamines. The agency said it will continue to watch for NDMA in medications, including metformin, and will provide updates as they become available.

Those who are taking metformin should not stop taking their medication, the FDA said. Stopping your medication can be dangerous. If you are considering stopping this medication, speak with your health care provider about your options.

Speak with your health care provider if you have any questions.

Written by Digital Pharmacist Staff



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